a study of irinotecan, levofolinate, and 5-fluorouracil (folfiri) plus ramucirumab (imc-1121b)

Conditions: Colorectal Carcinoma

Summary: the primary objective of this study is to investigate the safety and tolerability of the anti-vascular endothelial growth factor receptor-2 (anti-vegfr-2) monoclonal antibody ramucirumab (imc-1121b) in combination with irinotecan, levofolinate, and 5-fluorouracil (folfiri) in japanese participants with advanced colorectal carcinoma (crc).


Eligibility criteria:
inclusion criteria: * participant is japanese * has an eastern cooperative oncology group (ecog) performance status of 0 or 1 * has histologically or cytologically confirmed crc * has metastatic disease that is not amenable to potentially curative resection * has received no more than 2 prior systemic chemotherapy regimens in any setting (only 1 prior regimen for metastatic disease is permitted) * has received first-line combination therapy of bevacizumab, oxaliplatin, and a fluoropyrimidine for metastatic disease and has experienced disease progression during first-line therapy, or disease progression within 6 months after the last dose of first-line therapy, or discontinued part or all of first-line therapy due to toxicity and experienced disease progression within 6 months after the last dose of first-line therapy. participants must have received a minimum of 2 doses of bevacizumab as part of a first-line regimen containing chemotherapy in order to enroll. * has adequate hepatic, renal, hematologic, and coagulation function * the participant's urinary protein is ≤1+ on dipstick or routine urinalysis. if urine dipstick or routine analysis indicates proteinuria ≥2+, then a 24-hour urine must be collected and must demonstrate \<1000 milligrams (mg) of protein in 24 hours to allow participation in the study exclusion criteria: * has received bevacizumab within 28 days prior to study registration * has received chemotherapy within 21 days prior to study registration * has received any previous systemic therapy (other than a combination of bevacizumab, oxaliplatin, and a fluoropyrimidine) for first-line treatment of metastatic crc * the participant experienced any of the following during first-line therapy with a bevacizumab-containing regimen: an arterial thrombotic/thromboembolic event; grade 4 hypertension; grade 4 proteinuria; a grade 3-4 bleeding event; or bowel perforation * has received wide-field (full-dose pelvic) radiotherapy within 28 days prior to study registration * has undergone major surgery within 28 days or subcutaneous venous access device placement within 7 days prior to study registration * has elective or planned surgery to be conducted during the trial * has a history of deep vein thrombosis or pulmonary embolism within the past 12 months * has experienced any arterial thrombotic event within the past 12 months * participant is receiving therapeutic anticoagulation with warfarin, low-molecular weight heparin, or similar agents * participant is receiving chronic therapy with nonsteroidal anti-inflammatory agents \[aspirin up to 325 milligrams per day (mg/day) permitted\] * has a significant bleeding disorder or has had a significant (grade 3 or higher) bleeding event within 3 months prior to registration date * has a history of gastrointestinal perforation and/or fistulae within 6 months prior to registration date * has symptomatic congestive heart failure, unstable angina pectoris, or symptomatic or poorly controlled cardiac arrhythmia * has uncontrolled arterial hypertension despite standard medical management * has a serious or nonhealing wound, peptic ulcer, or bone fracture within 28 days prior to study registration * has an acute/subacute bowel obstruction or history of clinically significant chronic diarrhea * has a history of inflammatory bowel disease or crohn's disease requiring medical intervention within 12 months prior to registration date * the participant has either peptic ulcer disease associated with a bleeding event or known active diverticulitis * has an active infection requiring antibiotic, antifungal, or antiviral therapy * has known human immunodeficiency virus (hiv) infection or acquired immunodeficiency syndrome (aids)-related illness * has known leptomeningeal or brain metastases or uncontrolled spinal cord compression * has a known history of gilbert's syndrome, or is known to have any of the following genotypes: uridine diphosphate glucuronosyltransferase 1 family, polypeptide a1 (ugt1a1)\*6/\*6; ugt1a1\*28/\*28 or ugt1a1\*6/\*28 * has previous or concurrent malignancy, except for basal or squamous cell skin cancer and/or in situ carcinoma, or other solid tumors treated curatively and without evidence of recurrence for at least 3 years

Keywords: colon cancer rectal cancer